目的:系统评价阿达木单抗生物类似药临床互换用药的有效性、安全性与免疫原性，为临床互换用药提供循证参考。方法:系统检索Pubmed、Embase、Cochrane Library、CNKI、WAN-FANG、Sinomed等数据库中阿达木单抗生物类似药互换用药的 随机对照试验(randomized con-trolled trial，RCT)，检索时间为建库至2023年10月。对符合纳入标准的文献进行资料提取，并采用Cochrane系统评价手册5。0版推荐的偏倚风险评估工具进行偏倚风险评价，应用Revman 5。4软件进行Meta分析。对于证据体，采用Cochrane协作网推荐的GRADE工具进行质量分级。本项系统评价遵循PRISMA声明进行设计与实施。结果:共纳入18项研究，其中7项关注银屑病患者，11项关注类风湿关节炎患者。有效性方面，对于银屑病患者，与未转换用药相比，参照药与生物类似药间进行1～4次转换用药后PASI 75达标率与sPGA评分≤1达标率均无统计学差异(P＞0。05，中等质量证据)。对于类风湿关节炎患者，与未转换用药相比，参照药与生物类似药间进行1～3次转换用药后根据美国风湿病学会(american college of rheumatology，ACR)评估标准症状缓解20％(ACR 20)、缓解 50％(ACR 50)、缓解 70％(ACR 70)的达标率均无统计学差异(P＞0。05，中等质量证据)。安全性方面，对于银屑病与类风湿关节炎患者，与未转换用药相比，单次或多次转换用药后不良事件发生风险均无统计学差异(P＞0。05，中等质量证据)。免疫原性方面，对于银屑病与类风湿关节炎患者，与未转换用药相比，单次或多次转换用药后抗药抗体产生率无统计学差异(P＞0。05，中等质量证据)。目前尚缺乏其他适应证中阿达木单抗生物类似药互换用药的高质量循证医学证据。结论:阿达木单抗生物类似药与参照药间的转换用药未对银屑病及类风湿关节炎患者的治疗有效性、安全性、免疫原性造成影响。
Can adalimumab biosimilars be clinically interchanged:evidence based on a systematic review and Meta-analysis
AIM:To systematically evaluate the clinical interchangeability of adalimumab biosimi-lars in terms of efficacy,safety,and immunogenici-ty,and to provide evidence-based reference for clinical interchangeability.METHODS:Randomized Controlled Trials(RCTs)on the interchangeability of adalimumab biosimilars were systematically searched in PubMed,Embase,Cochrane Library,CNKI,WANFANG and SinoMed from inceptions to October 2023.Data were extracted from the litera-ture that met the inclusion criteria,risk of bias was assessed using the Cochrane Handbook for System-atic Reviews of Interventions 5.0 bias risk assess-ment tool.Meta-analysis was performed using Rev-man 5.4 software.The certainty of evidence was graded using the GRADE tool recommended by the Cochrane Collaboration.This study was conducted according to the PRISMA guideline.RESULTS:Eigh-teen studies were included,with 7 focusing on pso-riasis and 11 on rheumatoid arthritis.Regarding ef-ficacy,for psoriasis,there were no statistical differ-ences in PASI 75 response rates and sPGA scores of ≤1 after 1-4 switches between biosimilars and the reference drug(P＞0.05,moderate-quality evi-dence).For rheumatoid arthritis,there were no sta-tistical differences in ACR 20/50/70 response rates after 1-3 switches(P＞0.05,moderate-quality evi-dence).Regarding safety,there were no statistical differences in the risk of adverse events after single or multiple switches for both diseases(P＞0.05,moderate-quality evidence).Regarding immunoge-nicity,there were no statistical differences in the rate of anti-drug antibody production after single or multiple switches(P＞0.05,moderate-quality evi-dence).High-quality evidence is still lacking for the interchangeability of adalimumab biosimilars in other indications.CONCLUSION:The switches be-tween adalimumab biosimilars and the reference drug have no significant impact on clinical efficacy,safety and immunogenicity for psoriasis and rheu-matoid arthritis patients.
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